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In this section: Office of Regulatory Affairs

Contact ORA

Report a problem with FDA-regulated products
Resolve a Dispute
Find a FDA/ORA Staff Member
Stay Informed
For Industry

Report a problem with FDA-regulated products

If this is an emergency

If you are experiencing a life-threatening medical emergency, call 9-1-1.
To report an emergency involving food, drugs, medical devices, dietary supplements, or cosmetics, call 1-866-300-4374 or 1-301-796-8240.

By phone:

Call 1-888-INFO-FDA (1-888-463-6332).
Call the FDA Consumer Complaint Coordinator for your state or region.

For more details, see How to Report a Problem

Online:

Report Suspected Criminal Activity: If you wish to report suspected criminal activity relating to FDA regulated products.
MedWatch: Use the MedWatch Online Reporting Form to report adverse events with human food and medical products or call 800-332-1088.
To report the unlawful sale of an FDA-regulated medical products on the internet. If the product involves a life-threatening situation call 1-866-300-4374.

Resolve a Dispute

Contact the ORA Ombudsman

Find a FDA staff member

ORA Directory – Full contact information for ORA headquarters and field offices.
ORA Field Leadership Contacts
ORA District Directors
ORA Public Affairs Specialists - (PAS) are key links between the Agency and our constituents throughout the United States and Puerto Rico. They serve as FDA community-based educators.
FDA Import Contacts and Office Locations
ORA Recall Coordinators
Search the HHS employee directory (includes FDA employees)

Stay informed

For Industry

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